We applaud DBHDS efforts to improve these regulations and clarify expectations. We support the removal of the requirement of reporting for Level 1 serious incidents and the clarification that Case Managers are not required to duplicate Level II reporting of incidents that occur in other licensed programs.

12VAC-35-105-20 Definitions

The definition of “Licensed mental health professional” does not have a proposed change but should be expanded to include Licensed Nurse Practitioners.

The proposed definition of “serious incident’ as any event or circumstance that causes or could cause harm to the health, safety, or well-being of an individual does not sufficiently identify serious incidents and could result in significant over-interpretation.  Unemployment, homelessness, witnessing a crime, loss of a caregiver, lack of legal presence, addiction of a family member, deployment or serious illness of a parent, etal are examples of circumstances that could cause harm to the well-being of an individual and I believe are outside the intent of this regulation and the purview of DBHDS.

The proposed definition of “Level II serious incident” needs further clarification. “during the provision of a service or on the premises of a provider” particularly as it applies to “an individual who is missing.” Are we correct in assuming that a missing person is only a reportable Level II incident for providers who are responsible for individuals 24 hours per day?  Would a missed appointment with a Case Manager, Psychiatrist, Therapist, ICT or Skill Building provider be interpreted to occurring “during the provision of a service” and thus be reportable as a Level II incident since they could represent “circumstances in which an individual is not physically present when and where he should be and his absence cannot be accounted for or explained by his supervision needs or patterns of behavior”.

Also in the proposed definition of “Level II serious incident” #7a, a decubitus ulcer is only reportable if diagnosed. This could be a disincentive for a provider in seeking medical treatment for suspected ulcers which is not the intent of the regulation.

The proposed definition of “Level III serious incident” needs clarification specifically as it applies to:

1. “A sexual assault of an individual.” Guidance issued by DBHDS further states “Providers shall report to the department and other relevant authorities as required by law that an individual alleges they were sexually assaulted, whether or not the alleged assault occurred within the provision of the provider’s services or on their property.”  We support the reporting of sexual assaults that occur on the premises of a provider or against those individuals for whom we have 24-hour responsibility, we do not support reporting of all sexual assaults revealed by our clients to DBHDS.
   1. Reporting of assaults should be the prerogative of victims with capacity. Trauma Informed Care principals emphasize that the survivor have a genuine choice to direct reporting of victimization when possible.
   2. Regulations indicate assaults should be reported within 24 hours of discovery. Clients often reveal assaults years after they occur. If the assault occurred in the community, what purpose would the reporting serve?
   3. What role would DBHDS have in investigating/mitigating sexual assaults that occur in the community?
   4. “Sexual assault” is not defined
   5. Guidance in the Violence Against Women Act (VAWA) cautions against sharing information beyond minimum necessary since even the most secure systems can be compromised leaving sensitive information exposed, and survivors in danger and often unwilling to disclose their abuse and get help

1. “A serious injury of an individual that results in or likely will result in permanent physical or psychological impairment”. Further guidance issued by DBHDS states “For example, providers shall report if an individual had to have a leg amputated as a result of a car accident whether or not the car accident occurred within the provision of the provider’s services or on their property.” We support the reporting of serious injuries that occur on the premises of a provider, during the provision of services, or for those individuals for whom we have 24-hour responsibility, we do not support reporting of all injuries of this type to DBHDS. What role would DBHDS have in investigating/mitigating serious injuries sustained by clients in outpatient programs that occur in the community? While providers have a role in helping individuals process the trauma and linking to needed resources, we have no capacity for root cause analysis or mitigation of traffics accidents, acts of god, acts or war, crime, etc.

The definitions of QMHP-A and QMHP-C are not aligned with the new requirements for those staff to be registered with the Board of Counseling which can lead to misinterpretation of the requirements necessary to deliver services.

12VAC35-105-160. Reviews by the department; requests for information; required reporting.

“E. A root cause analysis shall be conducted by the provider within 30 days of discovery of Level II and Level III serious incidents. The root cause analysis shall include at least the following information: (i) a detailed description of what happened; (ii) an analysis of why it happened, including identification of all identifiable underlying causes of the incident that were under the control of the provider; and (iii) identified solutions to mitigate its reoccurrence.”

We support the root cause analysis following most incidents classified as Level II or Level III, conducting an analysis on the expected deaths from natural causes of individuals in outpatient programs  is unnecessarily burdensome.

12 VAC35-105-1245

“Case managers shall meet with each individual face-to-face as dictated by the individual’s needs. At face-to-face meetings, the case manager shall (i) observe and assess for any previously unidentified risks, injuries, needs, or other changes in status; (ii) assess the status of previously identified risks, injuries, or needs, or other change in status; (iii) assess whether the individual's service plan is being implemented appropriately and remains appropriate for the individual; and (iv) assess whether supports and services are being implemented consistent with the individual's strengths and preferences and in the most integrated setting appropriate to the individual's needs.”  Clients are often seen face to face by their case managers multiple times per month – a frequency interval for this extensive documentation requirement would be helpful.

12VAC35-105-1250. Qualifications of case management employees or contractors

“D. Case managers serving individuals with developmental disability shall complete the DBHDS core competency-based curriculum within 30 days of hire.” There is no contingency here for when the DBHDS portal is not available for over 30 days and DBHDS has no back-up training plan. We have experienced an outage of over 30 days in the past.

• 12VAC35-105-20, Definitions of serious incidents – Level II definition #6, “Ingestion of any hazardous material”  which must be reported “If any individual drinks, swallows, or absorbs a material that is hazardous to their health…it shall be reported.” We serve many individuals who engage in PICA.  Calls to the Poison Control Center direct us on whether to seek emergency care, or if we can provide treatment and monitoring at our sites.  We request requiring reporting only when the individual is taken to receive emergency or urgent professional medical care after ingesting any material, rather than after each occurrence of ingesting by individuals who engage in  PICA.  (Responses to their PICA behavior are driven not only by the Poison Control Center, but by individual protocols, behavior plans, and/or physician’s orders.)

• 12VAC35-105-20, Definitions of serious incidents – “Level III serious incident means serious incidents whether or not the incident occurs on the provider’s premises or within the provision of services. All providers that are made aware of a level III serious incident are required to report even if this results in duplicative reporting.”  Level III, definition #1, “Any death of an individual” – When using the CHRIS system to report deaths of individuals who did not die while in our licensed program, the system requires providers to answer questions to which we lack answers.  After choosing “yes” or “no” as required, we can only explain in a random textbox within CHRIS that the answers are in fact unknown.  We ask that instead of using CHRIS, a provider be required to notify OL of all deaths via a documented phone call or encrypted email.  Only the provider in whose care the individual died should be required to enter the death into the CHRIS system. 

• 12VAC35-105-160, “Amend to require reporting of all level II and level III serious incidents to the department,” “A root cause analysis shall be conducted by the provider within 30 days of the discovery of Level II and Level III serious incidents,” and “The provider shall submit, or make available, reports and information that the department requires to establish compliance with these regulations and application statutes.”  We appreciate the importance of tracking, analyzing, and reporting data on serious incidents state-wide.  This is important to monitor services and to protect the safety of individuals served, not just for compliance with the Settlement Agreement.  We request that the Comprehensive Human Rights Information System (CHRIS) be updated, or that another “web-based reporting application” replace it.  The system used should be user-friendly and should require entry of all mandated information and only that information, specific to categories of serious incidents, so that only one reporting mechanism is used.  Providers appreciate the availability of OHR staff to train and re-train staff on the use of CHRIS; such training is not a substitute for resolving system issues that now use considerable staff hours due to technical difficulties.

• Sections 20 and 691 – These sections and probably others refer to the individual and/or the individual’s “authorized representative.”  “Authorized representative” has a specific definition in the Code of Virginia.  If the regulations intentionally reference that Code definition, then the term “legal guardian” should be added to these and other sections where only an authorized representative is mentioned.  If on the other hand, “authorized representative” is intended as a generic term, then perhaps “substitute decision-maker” should be used instead.  12VAC35-115-145 does use the generic term “substitute decision making.”

Loudoun County MHSADS Comments on Emergency Licensing Regulations

12VAC35-105-20. Definitions.

 “Serious Incident” –

• Determining if a hospital admission is a level II may be subjective and result in inconsistent reporting among providers. Unplanned psychiatric/medical hospital admission: what constitutes an unplanned hospital admission? For example, there are circumstances where an individual may be ECO’ed but decide to voluntarily admit herself to the hospital. At what point in the process is it “unplanned?”

• Defining “a sexual assault of an individual” as a level III incident poses a risk to the therapeutic relationship and violates an individual’s rights to privacy.  An individual who has been a victim of the sexual assault has been violated and should not be further violated by the provider disclosing the information to DBHDS if the assault did not occur during service provision “A sexual assault of an individual” should be moved to a level II incident.

• Defining “a serious injury of an individual that results in or likely will result in permanent physical or psychological impairment” as a level III incident presents multiple challenges in implementation.  First, there is ambiguity in interpreting what “results in or likely results in permanent physical or psychological impairment.”   Who determines when it causes or likely will cause “permanent” impairment?  Second, requiring this to be reported to DBHDS when not occurring during service delivery, creates an undue burden for providers.  Individuals do not have to tell providers about situations that occur outside of service provision.  How does reporting this information to DBHDS provide useful data for the provider or DBHDS?  How does this help those receiving services?  Finally, this may also violate an individual’s right to privacy.  For example, if an individual were in an accident outside of service delivery and required amputation, why would DBHDS need to know this information?

12VAC35-105-160. Reviews by the department; requests for information; required reporting.

• The required components of the root cause analysis described in E do not allow for the dignity of risk and imply that all Level II and Level III incidents have feasible mitigating solutions for identification.  Accidents happen, which cannot be prevented.  Section (iii) needs to be modified to indicate identifying “solutions to mitigate its reoccurrence” as possible.  Further, there should be clarification that an individual has the right to indicate they do not want the identified solutions implemented.  It must be clear that individuals have the right to choice and dignity of risk.

105-20 Definition of Serious Incident

Level II 2. An individual who is missing for any period of time…does this mean while in our care as in residential or day programs. Does this apply to all services such as outpatient services? Please define “time”. This should be a more focused reporting for residential and day services.

 Level II 4. If a client comes to the CSB to see a nurse and it is recommended to go to the doctor how would we know if the ER was being used in lieu of a primary care visit? Is this reportable? Does this include urgent care visit in lieu of seeing the PCP, even when the PCP offices are closed? How do we handle voluntary hospitalizations, are they considered unplanned? Are they reportable? We would only report hospitalizations we help with in level II? Considerations should be made to remove psychiatric hospitalizations as a reportable requirement.

 Level II. 7. a-b.  How will we know if a decubitus ulcer or a bowel obstruction occurred or originated on our premises or during provision of services for all licensed services such as outpatient services? Should be focused just for residential services.                    

Level III. For level III reporting, does the individual have the right to know what is being reporting to the state regarding what is shared with the provider?

Level III. 2. Sexual assault of an individual. In an outpatient service this has serious impacts on the therapeutic relationship as the individual may feel additionally victimized by the reporting and questioning from a root cause analysis completed. Shouldn’t the individual provide authorization to report, what about their right to privacy? This should not be a level III reporting and should be moved to level II.

Level III. 3. If a client was in a car accident, would this be reportable in Level III?   How does one assess, at the time, if something is “likely” to result in permanent physical or psychological (especially psychological) impairment?  What is your definition of psychological impairment?  To report to DBHDS when not occurring during service delivery, creates an undue burden for providers.  Individuals do not have to tell providers about situations that occur outside of service provision.

Level III. 4. Suicide Attempt.– What constitutes a suicide attempt? If a person talks about suicide and has a voluntary admission is that behavioral or suicidal?Is this reportable?

Level III.  How will we do a root cause analysis for events that happen not on our premises, as many Level III situations will occur that way?

• “A sexual assault of an individual.” “Providers shall report to the department and other relevant authorities as required by law that an individual alleges they were sexually assaulted, whether or not the alleged assault occurred within the provision of the provider’s services or on their property.”  
  • The reporting of sexual assaults that occur on the premises of a provider or against those individuals for whom we have 24-hour responsibility would be appropriate but reporting of all sexual assaults revealed by our clients to DBHDS would pose a risk to therapy and violates an individual’s rights to privacy. Sexual assault is a legal term and what role should the provider have in investigating something that occurred in the community and should be investigated by the police. Regulations indicate assaults should be reported within 24 hours of discovery. Clients often reveal assaults years after they occur as part of therapy.

• “E. A root cause analysis shall be conducted by the provider within 30 days of discovery of Level II and Level III serious incidents. The root cause analysis shall include at least the following information: (i) a detailed description of what happened; (ii) an analysis of why it happened, including identification of all identifiable underlying causes of the incident that were under the control of the provider; and (iii) identified solutions to mitigate its reoccurrence.”
  • For Level II incidents, there should be an accumulation of incidents to trigger a RCA such as two level 2 incidents w/in a 30 day period as an example. Also conducting an analysis on the expected deaths from natural causes of individuals in outpatient programs would be more burdensome to programs. 

• A serious injury of an individual that results in or likely will result in permanent physical or psychological impairment”.  “For example, providers shall report if an individual had to have a leg amputated as a result of a car accident whether or not the car accident occurred within the provision of the provider’s services or on their property.”
  • There is ambiguity in what “results in or likely results in permanent physical or psychological impairment.”  What determines when it causes or likely will cause “permanent” impairment? This should be spelled out more. 

105-20 Definitions

Definition of Missing - Further clarification is needed for this definition as it relates to all services. The definition seems broad. For example; If a person is expected to arrive at 10:00 for an appointment and they no show and we are unable to reach them, are they missing? If they no show for a second appointment is that missing? For individuals in outpatient services living on their own this information would not be timely.  It is recommended to narrow the focus to residential and day services.

Definition of QDDP - The definition of QDDP seems to be different in the draft licensing regulations than in the waiver emergency regulations and the waiver definition. The emergency regulations are more flexible for providers since it allows a substitution of experience for education whereas the licensing definition requires a BA,  MD or an RN.  Many providers have supervisory staff who have extensive  experience  but may not have completed their BA or their degree may not be in a human services area, suggesting for consistency, to use the same language as in the waiver emergency regulations.

105-160 - Reviews by the dept and added required reporting - Regulating that every serious incident must have an identified solution to mitigate its reoccurrence may not apply all incidents, for example; deaths as a result of natural causes. Level III, how will we do a root cause analysis for incident that are not on our premises, as many Level III situations may occur that way. For example; if a client dies in a car accident, how/would we do a root cause analysis of this situation?  The requirement to complete a root cause analysis should be changed to complete a root cause analyses when patterns or trends occur.    

105-400 - Criminal background checks and registry searches - Requiring a disclosure statement from the applicant for pending charges for any offense is not something we would be legally able to ask.

Thank-you for the opportunity to provide comments.

105-520 - Risk Management - The wording in the regulations “incorporate uniform risk triggers and thresholds as defined by the department” is undefined and should either be removed from regulations or defined in regulations  as this leaves it open for interpretation.

105-580 - Service description requirements - C.2. A description of care, treatment, training skills acquisition, or other supports provided. The term “acquisition” is awkward language.

105-650 - Assessment Policy - F. A. comprehensive assessment shall update and finalize the initial assessment. There are questions regarding this requirement and Same Day Access Services.  We have received feedback that two separate assessments are needed; the initial assessment and the comprehensive assessment, on our SDA form we now have to identify which part is the initial and which part is the comprehensive. This needs clarification as it relates to the State’s SDA initiatives.

105-665 - ISP requirements - A.11. Does this only apply to DD Waiver CD services? The ISP shall be distributed to the individual and others authorized to receive it. What if the individual does not want a copy of the ISP?

105-675 - Reassessments and ISP reviews -

A.  Update the ISP whenever there is “any” kind of change? Is the review not sufficient? Definitely, if something new that needs addressing but does this include every improvement outside of the review period?

D.2. Currently this is documented that the individual has met an objective, what additional documentation is being proposed?

D.3. Requiring a team meeting when individuals do not meet specific objectives is difficult.  Individuals may have many objectives to reach a goal and have several goals. Requiring a team meeting each time a specific objective is not meet will feel punitive to an individual who is trying to reach their goals and may dramatically impact direct service time. How is the team defined? So if an objective on the ISP that the client will visit the primary care office in the next quarter, and the client cancels the visit, do we bring the whole team together to discuss why the client cancelled the appointment?  Requiring the team to meet should be removed.

105-691 - Transition of individuals among services - Further clarification is needed to define transition/transfer. If an individual moves from one case management team to another case management team is this a transfer needing a transfer summary?

105-1245 -   Case Management direct assessments - This is too ambiguous—who determines how often the individual’s needs dictate face-to-face contact?  We have some occasions, when we are seeing case management clients multiple times in the same week for MH case management—would we have to do (I,ii,iii,iv)at each face-to-face visit?

The process of completing a Root Cause Analysis can be useful in determining the factors which contributed to an incident and therefore can be valuable to efforts in addressing systemic issues. However, not all incidents require the methodology of a Root Cause Analysis to understand the contributing factors and underlying issues of an incident.  Many accidents, injuries, and deaths are attributable to individual and self-evident causes. In such cases the exercise of conducting a Root Cause Analysis will yield no new or useful information to the provider.

Additionally, there are incidents which occur where providers will not have the means to determine all or even some of the factors which contributed to the incident. This is likely to be the case for some Level III incidents which occur outside of the purview of the providers’ services and facilities.  In cases where providers are unable to accurately determine the factors which contributed to an incident it makes little practical sense to complete a Root Cause Analysis.

For these reasons we recommend that the regulations be revised to state that during their review of incidents providers will take reasonable steps to determine the underlying causes of Level II and Level III incidents.  The regulations can then highlight the utilization of Root Cause Analysis as a preferred method for determining the factors which contributed to incident This maintains the requirement that providers examine incidents to determine their root causes but offers greater latitude to providers regarding how they meet this requirement. In cases where the cause of an incident is obvious providers may not need to take additional actions and in cases where providers could not reasonably know the cause of an incident they are free from the obligation of conducting a fruitless Root Cause Analysis.

Hampton – Newport News Community Services Board

Response to Proposed Changes to DBHDS – Emergency Regulations

1. 12VAC35-105-20. Definitions.

"Serious incident" means any event or circumstance that causes or could cause harm to the health, safety, or well-being of an individual. The term "serious incident" includes death and serious injury. "Level I serious incident" means a serious incident that occurs or originates during the provision of a service or on the premises of the provider and does not meet the definition of a Level II or Level III serious incident. "Level I serious incidents" do not result in significant harm to individuals, but may include events that result in minor injuries that do not require medical attention or events that have the potential to cause serious injury, even when no injury occurs. "Level II serious incident" means a serious incident that occurs or originates during the provision of a service or on the premises of the provider that results in a significant harm or threat to the health and safety of an individual that does not meet the definition of a Level III serious incident. "Level II serious incident" includes a significant harm or threat to the health or safety of others caused by an individual. "Level II serious incidents" include: 1. A serious injury; 2. An individual who is missing; 3. An emergency room or urgent care facility visit when not used in lieu of a primary care physician visit; 4. An unplanned psychiatric or unplanned medical hospital admission; 5. Choking incidents that require direct physical intervention by another person; 6. Ingestion of any hazardous material; or 7. A diagnosis of: a. A decubitus ulcer or an increase in severity of level of previously diagnosed decubitus ulcer; b. A bowel obstruction; or c. Aspiration pneumonia. "Level III serious incident" means a serious incident whether or not the incident occurs while in the provision of a service or on the provider's premises and results in: 1. Any death of an individual; 2. A sexual assault of an individual; 3. A serious injury of an individual that results in or likely will result in permanent physical or psychological impairment; or 4. A suicide attempt by an individual admitted for services that results in a hospital admission.

• The new assignment of Levels to serious incidents does not improve the accuracy or efficiency of reporting for Providers. This assignment system is confusing, inconsistent/contradicting and does not adequately address some of the most common types of incidents experienced by Providers. For example, serious incidents occurring offsite, but reported to Case Managers outside of service provision, are notably difficult to categorize in the existing reporting infrastructure. The proposed Level system, and subsequent guidance offered by DBHDS, do not offer the direction needed for adequate application.

• Level III incidents, such as sexual assault, may fall outside of the jurisdiction of a Provider to investigate, as it might impede the work of a law enforcement entity.

• In accordance to the proposed regulations, Level III serious incidents include those that result in or likely will result in permanent physical or psychological impairment. This is a highly subjective descriptor and, given the parameters for reporting serious incidents (e.g., timeframes), as well as completing the subsequent investigations, it is unlikely if the information needed to make this type of assumption would be available at the time of completion.

• The Definitions do not acknowledge or define the position of Qualified Mental Health Case Manager (QCM). Is a QCM equivalent to a QMHP? If not, a separate, distinct definition for a QCM should be provided, with information as to what qualifications distinguish it from the QMHP classification.

1. 12VAC35-105-160. Reviews by the department; requests for information; required reporting.

1. The provider shall collect, maintain, and review at least quarterly all Level I serious incidents as part of the quality improvement program in accordance with 12VAC35-105-620 to include an analysis of trends, potential systemic issues or causes, indicated remediation, and documentation of steps taken to mitigate the potential for future incidents.

• Given the amount of additional reporting, analysis and outcome maintenance the regulatory standards mandate, quarterly review of Level I incidents, which are frequent in number, is superfluous and burdensome on an already overtaxed system. At a minimum, an annual review of trends would be sufficient.

E. A root cause analysis shall be conducted by the provider within 30 days of discovery of Level II and Level III serious Regulations Volume 34, Issue 25 Virginia Register of Regulations August 6, 2018 2510 incidents. The root cause analysis shall include at least the following information: (i) a detailed description of what happened; (ii) an analysis of why it happened, including identification of all identifiable underlying causes of the incident that were under the control of the provider; and (iii) identified solutions to mitigate its reoccurrence.

• Implementation of this requirement should be delayed until: DBHDS has provided adequate training to Providers on how to conduct a Root Cause Analysis (RCA) that meets the Department’s standards; provides the method by which Providers should document RCAs to ensure the Department’s standards are met.

• RCAs should not be applied universally to all Level II and Level III serious incidents. Deaths of unknown cause, some sexual assaults offsite and outside of service provision, etc. are types of events when an RCA should not apply.

• Sensitivity to the nature of “investigating” and/or completing RCAs with victims of assault, especially ones of a sexual nature, does not appear to have been applied in the development of this regulatory standard. This requirement should be rescinded.

1. 12VAC35-105-520. Risk management.

C. The provider shall conduct systemic risk assessment reviews at least annually to

identify and respond to practices, situations, and policies that could result in the risk of harm to individuals receiving services. The risk assessment review shall address (i) the environment of care; (ii) clinical assessment or reassessment processes; (iii) staff competence and adequacy of staffing; (iv) use of high risk procedures, including seclusion and restraint; and (v) a review of serious incidents. This process shall incorporate uniform risk triggers and thresholds as defined by the department.

• Implementation of this requirement should be delayed until: DBHDS has provided adequate training to Providers on how to conduct systemic risk assessments that meet the Department’s standards, with special emphasis on the “uniform risk triggers and thresholds” as defined by the department, per the proposed regulations. Given the DOJ’s scrutiny and the Department’s increased emphasis in this area, it is imperative Providers have the support and training, facilitated by DBHDS, to ensure this standard is adequately applied.

1. 12VAC35-105-675. Reassessments and ISP reviews.

D. 3. For goals and objectives that were not accomplished by the identified target date, the provider and any appropriate treatment team members shall meet to review the reasons for lack of progress and provide the individual an opportunity to make an informed choice of how to proceed.

• This section should read “the provider and/or any appropriate treatment team members” to more adequately represent Providers offering services to individuals in mental health and ARTS programming. Although it is recognized a treatment team approach would be ideal in progress review, this option is not always readily available, even with care coordination support. The proposed writing of this portion of regulation might result in over interpretation or misapplication. 

HHF Public Comment 

Rules and Regulations For Licensing Providers by the Department of Behavioral Health and Developmental Services [12 VAC 35 ? 105] 

RE: the Root Cause Analysis: Additional training and information should be offfered to providers in order for this new expecation to be implemented well. As others have noted, there are certain circumstances when an RCA would not be feasible, due to the nature of the incident or the environment in which the incident occured.

RE: the QIDP/QDDP definitions: limiting the requirments to specific degrees removes from consideration professionals with significant experience in the field. Is it possible to include relevant work experiece as qualifying a professional to serve in this capacity?

.